Bonti Announces Dosing of the First Patient in the SHINE-1 Phase 2
Clinical Study Evaluating EB-001 for Scar Reduction

February 08, 2018 08:15 AM Eastern Daylight Time

NEWPORT BEACH, Calif.--(EON: Enhanced Online News)--Bonti, a privately-held, clinical-stage biotechnology company, today
announced the initiation of the SHINE (Scar
Healing Improvement
with Neurotoxin E)
clinical program, aimed at scar reduction using its novel neurotoxin.
The first clinical study, SHINE-1, is a randomized, placebo-controlled,
double-blind, parallel arm trial to evaluate the safety and efficacy of
EB-001 injections in patients undergoing Mohs micrographic surgery on
the forehead. EB-001 is a novel botulinum neurotoxin serotype E
(BoNT/E) with a unique product profile, characterized by fast onset of
action (within 24 hours) and a short duration of effect (about 4 weeks).
Considering the potential advantages of this profile, Bonti continues
developing products to pursue targeted aesthetic and therapeutic
indications in areas of unmet needs with significant addressable market
opportunities.

In a proof-of-concept Phase 2A clinical study in 2017, EB-001 met its
primary endpoint in the treatment of glabellar (frown) lines and was
well tolerated. Dose ranging results from that study confirmed dose
selection for the SHINE-1 study. The SHINE-1 study will evaluate a
single intra-operative treatment of EB-001 intramuscular injections into
the forehead muscles underlying the surgical wound following the Mohs
procedure. The primary efficacy outcome measures to evaluate wound
healing improvement and scar formation reduction include a Visual Analog
Scale (VAS) and a Scar Cosmesis Assessment and Rating (SCAR) scale.

“We are excited about the start of our SHINE scar reduction clinical
program. As a key facet of developing novel treatment paradigms driven
by our unique biologic platform, EB-001 has the potential to help
physicians repair ‘cosmetically sensitive’ wounds leading to improved
outcomes for patients,” said Fauad Hasan, CEO and co-founder at Bonti.
“The Mohs surgical model will serve as an excellent model for
demonstrating proof-of-concept for our therapy because it is widely used
on millions of patients in the United States annually and because it is
representative of the face and neck scars which physicians and patients
are eager to address. The potential use of EB-001 for scar reduction is
yet another way in which our differentiated botulinum neurotoxin
may benefit patients and physicians alike.”

“EB-001 can potentially help me address scarring, one of my patients’
most significant concerns following face and neck surgery,” commented
Murad Alam, MD, Vice Chair, and Professor of Dermatology at Northwestern
University’s Feinberg School of Medicine and a Mohs surgeon. “I’m always
thinking about how to improve patient outcomes and the overall patient
experience so working with a tool such as EB-001 which may help me
address these areas is exciting to consider. EB-001’s unique neurotoxin
target profile, with a fast onset and short duration, may be ideal to
help us achieve what’s best for patients aesthetically following Mohs
and other surgeries.”

SHINE Clinical Program

The SHINE (Scar Healing
Improvement with Neurotoxin
E) clinical program’s main objective
is to support Bonti’s strategy to expand EB-001’s potential aesthetic
indications. This requires conducting multiple clinical trials, starting
with a Phase 2 study such as SHINE-1 in the Mohs surgery model.

About EB-001

Bonti’s lead product candidate, EB-001, is an investigational botulinum
neurotoxin serotype E (BoNT/E). EB-001 has a mechanism of action similar
to the marketed botulinum neurotoxin serotype A (BoNT/A) products
though it has a differentiated clinical profile. EB-001 has a fast onset
of action (within 24 hours) and a short duration of effect (about 4
weeks). Currently marketed BoNT/A products have an onset of action of 3
– 7 days and a duration of effect of 3 – 4 months. The unique target
clinical profile of EB-001 may be well suited for a vast range of
aesthetic and therapeutic uses, including for the treatment of
post-surgical and non-surgical musculoskeletal pain, with currently
unmet needs.

About Bonti

Bonti, based in Newport Beach, California, is a rapidly emerging
biotechnology company founded by world class neurotoxin and biologics
experts with proven prior success at Allergan and Halozyme. This team,
with deep neurotoxin, aesthetic and pain expertise, is uniquely
qualified to develop treatment paradigms driven by a novel neurotoxin
platform designed to become an innovative leader in both aesthetic and
therapeutic markets. By turning the science of neurotoxins into
beneficial patient and healthcare provider solutions, Bonti seeks to
improve lives by successfully addressing key unmet needs.